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FDA's Approval was Postponed Again, Chinese Innovative Pharmaceutical Companies has Extended Their Businesses to the Middle East and North Africa
PharmaSources
April 27, 2023
The export of domestic PD-1 is much more difficult than expected.The Middle East and North Africa has become a new choice for the export of domestic innovative pharmaceutical companies in the past two years.
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Pharma packaging regulations of NMPA, EMA and FDA
Muhammad Asim Niazi
March 21, 2023
There are various regulatory bodies globally that take part in constituting packaging regulations. The pharma manufacturer is requires to comply with the regulations of body, in which it intends to produce or market its manufactured drug.
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Why Drug regulatory authority updates their Rules and Regulations
Muhammad Asim Niazi
March 21, 2023
Pharmaceutical regulatory authorities regularly update their rules and regulations regarding drug review and approval.
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Pharma Co-packaging Regulations
Muhammad Asim Niazi
March 21, 2023
Let’s discuss some regulatory requirements for contract packaging in line with three most competitive markets i.e China , United States and Europe.
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Drug Marketing in China and Worldwide (July)
Caicai/PharmaSources
August 11, 2023
On July 6th, Eisai's lecanemab (Leqembi) was fully approved by the FDA for the treatment of Alzheimer's disease
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3D Printing: A Perfect Storm for Pharma Industry and Regulatory Agency
PharmaSources/Eric Sun, Ph.D.
April 12, 2022
3D printing or additive manufacturing is a process of creating three-dimensional solid objects from a digital design. The process involves printing sequentially thin layers of the building materials until the object is created.
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Weekly Pharma News Review | PharmaSources.com (April.18th - 22ed)
PharmaSources.com
April 27, 2022
The pharma news review of this week totally covers 22 pieces of news in 3 sections, including drug review, R&D, and business.
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Updates on the Bioequivalence Studies for Drugs Submitted to Under an ANDA
Lin Zhang
April 08, 2022
From time to time, the Food and Drug Administration (FDA) offers a lot of updates to its materials and practices, and any person involved with the industry needs to stay alert for new releases, educational events, and training.
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A Brief Overview of the FDA Bioresearch Monitoring (BIMO) Program
Lin Zhang
April 08, 2022
The U.S. Food and Drug Administration (FDA) held a webinar on the Bioresearch Monitoring program (BIMO) last month (2/16/2022).
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Going Global Successfully! BCMA CAR-T of Legend Biotech is Approved by FDA for Marketing!
PharmaSources/Small pill
March 16, 2022
On February 28 local time, LEGN.US officially announced in Somerset, New Jersey, U.S., that its self-developed BCMA-targeted CAR-T therapy, ciltacabtagene autoleucel (trade name: CARVYKTI®), abbreviated as Cilta-cel, was approved for marketing by the FDA.